Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes

NCT07317115 | Recruiting

• 1 other identifier: GTM-021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).

Conditions

Obesity (Disorder); Obesity & Overweight; Type 2 Diabetes (T2DM)

Keywords

Magnet System; Semaglutide; GT Metabolic Solutions, Inc.

Outcome Measures

Primary Outcomes (1)

• Functional improvement of T2D: HbA1c

  Day 360

Study Arms (2)

Surgery Arm

ACTIVE COMPARATOR

Magnet System

Device: Magnet System

Medication Arm

ACTIVE COMPARATOR

Semaglutide

Drug: Semaglutide

Interventions

Magnet System DEVICE

Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition

Surgery Arm

Semaglutide DRUG

Semaglutide (up to 2.4mg subcutaneous (SQ) injection weekly or dose tolerated according to side effects); a glucagon-like peptide-1 receptor agonist (GLP-1RA)

Medication Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) between 30 - 40 kg/m2 and qualifies for obesity treatment at the discretion of the treating investigator (i.e., must be assessed to qualify for both surgery and medication treatment to justify randomization).
• Type 2 diabetes (T2D defined as HbA1c ≥ 6.5%).
• Participant agrees to refrain from additional metabolic and bariatric (MBS) or reconstructive surgery that would affect body weight for the duration of the study.
• Participant agrees to refrain from taking any additional semaglutide-containing or other GLP-1RA medication for the duration of the study, regardless of randomization assignment (i.e., Surgery or Medication).
• Participant has been informed of the nature of the study and is willing and able to comply with requirements, including randomization, and provides written informed consent to participate in the study.

You may not qualify if:

• Meets any of the contraindications for either treatment arm (Surgery: Magnet System; or Medication: semaglutide), thereby prohibiting randomization
• Current or previous metabolic and bariatric surgery (MBS) treatment in the previous 12 months (e.g., sleeve gastrectomy, intragastric balloons, adjustable gastric banding).
• Taking or treated with semaglutide, semaglutide-containing medications, or any other GLP-1RA medication in the previous 12 months.
• Pregnant, lactating or planning pregnancy during the clinical study and follow-up period.
• Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study.
• Presence of other anatomic or comorbid conditions, or medical, social or psychological conditions that, in the investigator's opinion, would contraindicate either treatment arm or could limit the participant's ability to participate in the clinical study or to comply with follow-up requirements.

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (1)

Westmount Surgical Center

Westmount, Quebec, H3Z 2P9, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Lisa Griffin Vincent, PhD, MA

CONTACT

+1 763-200-1416; clinical@gtmetabolic.com

Josh Schumacher

CONTACT

+1 763-200-1416; clinical@gtmetabolic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization of Surgery (MagDI System) versus Medication (semaglutide). At Day 360, subjects in the Medication arm will have the option to crossover to the Surgery Arm.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)